MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE®, SPIROS® W/; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3700
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used ch3700 smallbore trifuse ext set w/3 chemoclave, spiros for inspection.As received, the spin feature on the spiros was activated and spinning freely.No spline damage or shear tab anomalies were observed.The spiros was fully connected and bonded to the distal end of the trifuse.The bond area was examined under ultraviolet (uv) light and was found to have sufficient coverage.The spiros showed no propensity to disconnect from the set.The spiros were functionally tested and met product specifications.The reported complaint was unable to be replicated or confirmed.A device history review (dhr) lot# review could not be conducted because no lot number(s) was/were identified.
Event or Problem Description
It was reported that a 5.5" (14 cm) appx 0.55 ml, smallbore trifuse ext set w/3 chemoclave®, spiros® w/red cap, 3 clamps was found to have separated during patient use.The report stated that the spiros at the end of the trifuse pops off of the tubing.Found as they tried to hook it up and start chemo.It will attach but if you barely touch/spin it, it falls off the tubing.There was no patient harm reported.

• Brand Name: 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE®, SPIROS® W/
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21511422
• Report Number: 9617594-2025-00394
• Device Sequence Number: 4448966
• Product Code: ONB
• UDI-Device Identifier: 00887709089181
• UDI-Public: 00887709089181
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CH3700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMO, UNK MFR
• Patient Sex: Unknown